Department

BSD PED - Clinical Trials Office: COG and HemOnc Research

About the Department

In the Department of Pediatrics at the University of Chicago, we strive to provide the highest level of complex care for children from diagnosis and treatment to conducting research to find promising new therapies with a focus on teaching. We are committed to advancing the frontiers of knowledge, and the education and training of future clinical pediatricians, subspecialists, educators, clinical investigators and physician-scientists. The Department of Pediatrics is a dynamic, stimulating place to work, and because we are focused on growth and improved excellence, our staff have particularly challenging and rewarding roles.

The Pediatric Clinical Trials Office (Peds CTO) is an existing centralized support office that provides services and high-level guidance to individuals (faculty, investigators, research staff, and clinic coordinators from the University and Hospital) involved in human subjects research. The Peds CTO is responsible for establishing standards, operating procedures, policies and practices, implementing educational and training programs, developing communication tools, and managing the administrative functions that impact individuals involved in clinical research.

Job Summary

The Clinical Research Coordinator 2 (CRC2) provides support to the Section of Pediatric Hematology and Oncology. The CRC2 will be involved in multiple research trials types: investigator-initiated, multi-centered cooperative group studies, multi-institutional pharmaceutical trials, and multi-centered trials designed, implemented, and coordinated in the Section including but not limited to solid tumor and central nervous system research and clinical trials. The CRC2 is a specialized researcher partnering with the Principal Investigator (PI) and under the direction of leadership in the Peds CTO. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC2 supports, facilitates, and coordinates independently the daily clinical research activities and plays a critical role in the conduct of the study.  By performing these duties with limited supervision and/or guidance, the CRC2 works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.

​​​Our department follows a hybrid work structure that fosters productivity, collaboration, and employee well-being. Working from the office is encouraged for tasks that require a high degree of collaboration.

Responsibilities

Analyzes, facilitates and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, and participation in program audits. 

Prepares program conference lists for multidisciplinary conferences and workshops. Participates in all pharmaceutical site visits. Uses moderate understanding of clinical trials to collect and store patient specimens, radiology scans and reports. 

Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study. 

Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports with guidance from PI and other clinical research staff.   

Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.   

Identify and explain the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.   

Coordinate the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.   

Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.   

Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures.   

Performs assessments at visits and monitors for adverse events.   

Organizes and attends site visits from sponsors and other relevant study meetings.   

Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.   

Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.   

Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.   

Controls the acquisition/collection, abstraction, processing, privacy, and quality assurance for all clinical research data required for the protocol. Responsibilities include, but are not limited to: provide efficient and complete data collection, processing, analysis and reporting; assure source documentation and data abstraction and entry are being done at the protocol specified time-points; ensure data accuracy and integrity by working closely with internal monitors and/or auditors to promptly resolve any data quality concerns or outstanding queries; and, facilitate the exchange of data across projects and organizations.  

Understand the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently.   

Ensures compliance with federal regulations and institutional policies.   

May prepare and maintain protocol submissions and revisions.   

May assist in the training of new or backup coordinators.   

Analyzes protocols and advise treating physicians on appropriate dosage modifications or treatment calculations.  

Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.   

Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.   

Accountable for all tasks in moderately complex clinical studies. 

Assists with various professional, organizational, and operational tasks under moderate supervision. 

Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits. 

Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples with a limited to moderate degree of independence. Contributes to the problem solving on assigned clinical research studies and tasks.  

Performs other related work as needed. ​

Minimum Qualifications

Education:

Minimum requirements include a college or university degree in related field.

Work Experience:

Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

Certifications:

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Preferred Qualifications 

 

Education: 

Bachelor’s degree. 

 

Experience: 

2 years of clinical research experience coordinating multiple and variety of studies (e.g., investigator-initiated; industry-sponsored; multi-site trials). 

 

Preferred Competencies 

Ability to communicate in writing. 

Ability to communicate orally. 

Ability to comprehend technical documents. 

Understanding of the federal research regulations and the ability to identify the federal research organizations’ role in regulating human research participation. 

Ability to develop and manage interpersonal relationships. 

Ability to exercise absolute discretion regarding confidential matters. 

Ability to follow written and/or verbal instructions. 

Ability to handle sensitive matters with tact and discretion. 

Ability to handle stressful situations. 

Ability to learn and develop skills. 

Ability to maintain a high level of alertness. 

Ability to pay attention to detail. 

Ability to perform multiple tasks simultaneously. 

Ability to prioritize work and meet deadlines. 

Ability to react effectively, quickly, calmly, and rationally during conflicts and emergencies. 

Ability to work effectively and collegially with little supervision or as member of a team. 

Ability to work independently. 

Ability to participate in protocol review and clinical trials evaluations. 

Excellent interpersonal skills. 

Strong data management skills and attention to detail. 

Strong organizational skills. 

Experience in managing NIH funded grants. 

Ability to handle competing demands with diplomacy and enthusiasm. 

Ability to work collaboratively with faculty and divisional clinical research infrastructure. 

Excellent time management and ability to prioritize work assignments. 

Ability to read and understand clinical trials protocols. 

Familiarity with medical terminology/environment. 

Working knowledge of Good Clinical Practices (GCP). 

Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat. 

Working Conditions 

Eligible for hybrid work based on business needs and the demands of specific tasks. Working from the office is encouraged for tasks that require a high degree of collaboration. 

 

Application Documents 

Resume (required) 

Cover Letter (required)

When applying, the document(s) MUST be uploaded via the My Experience page, in the section titled Application Documents of the application.

Job Family

Research

Role Impact

Individual Contributor

Scheduled Weekly Hours

40

Drug Test Required
 

Yes

Health Screen Required
 

Yes

Motor Vehicle Record Inquiry Required
 

No

Pay Rate Type

Salary

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FLSA Status

Exempt

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Pay Range

$56,000.00 - $70,000.00

The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.

Benefits Eligible

Yes

The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.

Posting Statement
 

The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, national or ethnic origin, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.

 

Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via Applicant Inquiry Form.

 

We seek a diverse pool of applicants who wish to join an academic community that places the highest value on rigorous inquiry and encourages a diversity of perspectives, experiences, groups of individuals, and ideas to inform and stimulate intellectual challenge, engagement, and exchange.

 

All offers of employment are contingent upon a background check that includes a review of conviction history.  A conviction does not automatically preclude University employment.  Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.

 

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